Diabetes Mellitus, Type 2Phase 2NCT00479466

Dose-Range Finding Study for MK0893 (0893-008)

A Phase 2 study testing MK0893 and Metformin in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus). Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: MK0893 and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 342 participants
Where: No sites listed yet
Study dates: Jul 2007to May 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Who cannot join

Patients have a history of Type 1 Diabetes Mellitus
Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist)
Patients who have a contraindication to metformin

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Conditions: Diabetes Mellitus, Type 2
Being tested: MK0893, Metformin, Placebo to MK0893, Placebo to Metformin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK0893Drug
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
MetforminDrug
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
Placebo to MK0893Drug
Dose-matched placebo tablets to MK0893; taken orally once daily.
Placebo to MetforminDrug
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Study groups in NCT00479466
Study group	Role	What they receive
MK0893 80 mg	Experimental	MK0893 tablets totaling 80 mg once daily. Receives: Drug: MK0893; Drug: Placebo to MK0893; Drug: Placebo to Metformin
MK0893 60 mg	Experimental	MK0893 tablets totaling 60 mg once daily. Receives: Drug: MK0893; Drug: Placebo to MK0893; Drug: Placebo to Metformin
MK0893 40 mg	Experimental	MK0893 40 mg tablet once daily. Receives: Drug: MK0893; Drug: Placebo to MK0893; Drug: Placebo to Metformin
MK0893 20 mg	Experimental	MK0893 20 mg tablet once daily. Receives: Drug: MK0893; Drug: Placebo to MK0893; Drug: Placebo to Metformin
Metformin	Active comparator	Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. Receives: Drug: Metformin; Drug: Placebo to MK0893
Placebo	Placebo comparator	PLA tablets. 12 week treatment period. Receives: Drug: Placebo to MK0893; Drug: Placebo to Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Measured: Week 12

Secondary outcomes (2)

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Measured: Week 12
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007May 2008

First posted28 May 2007 (estimated)
Study startJul 2007
Primary completionMay 2008
Study completionMay 2008

Why it stopped: Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00479466
Sponsor's protocol ID: 0893-008
Other IDs: 2007_526
Status last verified: Sep 2015
First submitted: 25 May 2007
Last updated: 9 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00479466
Acronym / sponsor ID: 0893-008
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy
Enrolment: 342 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 28 May 2007 (estimated)
Results: Posted 11 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
MK0893 80 mg	Experimental	Drug: MK0893, Drug: Placebo to MK0893, Drug: Placebo to MetforminMK0893 tablets totaling 80 mg once daily.
MK0893 60 mg	Experimental	Drug: MK0893, Drug: Placebo to MK0893, Drug: Placebo to MetforminMK0893 tablets totaling 60 mg once daily.
MK0893 40 mg	Experimental	Drug: MK0893, Drug: Placebo to MK0893, Drug: Placebo to MetforminMK0893 40 mg tablet once daily.
MK0893 20 mg	Experimental	Drug: MK0893, Drug: Placebo to MK0893, Drug: Placebo to MetforminMK0893 20 mg tablet once daily.
Metformin	Active comparator	Drug: Metformin, Drug: Placebo to MK0893Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
Placebo	Placebo comparator	Drug: Placebo to MK0893, Drug: Placebo to MetforminPLA tablets. 12 week treatment period.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Key exclusion criteria (3 listed)

Patients have a history of Type 1 Diabetes Mellitus
Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist)
Patients who have a contraindication to metformin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK0893MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.	Drug	MK0893 20 mg, MK0893 40 mg, MK0893 60 mg, MK0893 80 mg
MetforminMetformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.	Drug	Metformin
Placebo to MK0893Dose-matched placebo tablets to MK0893; taken orally once daily.	Drug	MK0893 20 mg, MK0893 40 mg, MK0893 60 mg, MK0893 80 mg, Metformin, Placebo
Placebo to MetforminDose-matched placebo tablets to metformin (500 mg); taken orally twice daily.	Drug	MK0893 20 mg, MK0893 40 mg, MK0893 60 mg, MK0893 80 mg, Placebo

Primary outcome

Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Time frame: Week 12

2 secondary outcomes

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Time frame: Week 12
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
Time frame: Week 12

Results and safety

Results posted to the registry on 11 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	57	44
MK0893 20 mg	57	49
MK0893 40 mg	57	54
MK0893 60 mg	58	55
MK0893 80 mg	56	48
Metformin HCL	57	53

Primary outcome: Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)

Time frame: Week 12. Least squares mean (95% Confidence Interval). Unit: mg/dL

Measure	Placebo n = 54	MK0893 20 mg n = 55	MK0893 40 mg n = 57	MK0893 60 mg n = 57	MK0893 80 mg n = 54	Metformin HCL n = 57
Value	-1.8 (-11.4 to 7.8)	-32.4 (-41.7 to -23.2)	-48.4 (-57.4 to -39.5)	-53.0 (-61.9 to -44.1)	-63.0 (-72.4 to -53.7)	-37.3 (-46.3 to -28.4)

Placebo vs MK0893 20 mg: Mean Difference (Final Values): -30.6 (95% CI -44.0 to -17.3), p <0.001, ANCOVA
Placebo vs MK0893 40 mg: Mean Difference (Final Values): -46.6 (95% CI -59.7 to -33.4), p <0.001, ANCOVA
Placebo vs MK0893 60 mg: Mean Difference (Final Values): -51.1 (95% CI -64.3 to -38.0), p <0.001, ANCOVA

Population analysed: All participants who received at least one dose of study therapy, had a baseline measurement, and had at least one post-randomization measurement.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 57 (8.8%)	16 of 57 (28.1%)	Not reported
MK0893 20 mg	0 of 57 (0%)	11 of 57 (19.3%)	Not reported
MK0893 40 mg	1 of 57 (1.8%)	22 of 57 (38.6%)	Not reported
MK0893 60 mg	0 of 58 (0%)	16 of 58 (27.6%)	Not reported
MK0893 80 mg	2 of 56 (3.6%)	12 of 56 (21.4%)	Not reported
Metformin HCL	0 of 57 (0%)	13 of 57 (22.8%)	Not reported

Limitations and caveats (from the sponsor): Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy, thus the study was discontinued.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK0893 and Metformin in people with Diabetes Mellitus, Type 2, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00479466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015; AzTrials last refreshed its copy on 31 Oct 2026.